System and method for treatment of non-ventilating middle ear by providing a gas pathway through the nasopharynx

ABSTRACT

Methods and devices for providing a gas pathway between the nasopharynx and the Eustachian tube are provided. One device may include a lumen with a valve. A portion of the valve may be tethered to adjacent muscle. Another portion of the valve may be tethered to adjacent cartilage. When the muscle contracts the valve may open through movement of the tethers, and provide a gas pathway between the nasopharynx and the Eustachian tube.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/722,300, issued as U.S. Pat. No. 9,636,258 on May 2, 2017, which is acontinuation of U.S. patent application Ser. No. 13/887,618, issued asU.S. Pat. No. 9,072,626 on Nov. 14, 2013, which is a continuation ofU.S. patent application Ser. No. 12/730,492, issued as U.S. Pat. No.8,435,290 on Dec. 2, 2010, which claims the benefit of U.S. ProvisionalPatent Application Ser. No. 61/165,448, filed Mar. 31, 2009, the fulldisclosure of which is hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention is related to methods and systems for accessing,diagnosing and/or treating target tissue regions within the middle earand the Eustachian tube.

Referring to FIGS. 1-2, the ear 10 is divided into three parts: anexternal ear 12, a middle ear 14 and an inner ear 16. The external ear12 consists of an auricle 18 and ear canal 20 that gather sound anddirect it towards a tympanic membrane 22 (also referred to as theeardrum) located at an inner end 24 of the ear canal 20. The middle ear14 lies between the external and inner ears 12 and 16 and is connectedto the back of the throat by a Eustachian tube 26 which serves as apressure equalizing valve between the ear 10 and the sinuses. TheEustachian tube 26 terminates in a distal opening 28 in the nasopharynxregion 30 of the throat 32. In addition to the eardrum 22, the middleear 14 also consists of three small ear bones (ossicles): the malleus 34(hammer), incus 36 (anvil) and stapes 38 (stirrup). These bones 34-38transmit sound vibrations to the inner ear 16 and thereby act as atransformer, converting sound vibrations in the canal 20 of the externalear 12 into fluid waves in the inner ear 16. These fluid waves stimulateseveral nerve endings 40 that, in turn, transmit sound energy to thebrain where it is interpreted.

The Eustachian tube 26 is a narrow, one-and-a-half inch long channelconnecting the middle ear 14 with the nasopharynx 30, the upper throatarea just above the palate, in back of the nose. The Eustachian tube 26functions as a pressure equalizing valve for the middle ear 14 which isnormally filled with air. When functioning properly, the Eustachian tube26 opens for a fraction of a second periodically (about once every threeminutes) in response to swallowing or yawning. In so doing, it allowsair into the middle ear 14 to replace air that has been absorbed by themiddle car lining (mucous membrane) or to equalize pressure changesoccurring on altitude changes. Anything that interferes with thisperiodic opening and closing of the Eustachian tube 26 may result inhearing impairment or other ear symptoms.

Obstruction or blockage of the Eustachian tube 26 results in a negativemiddle ear pressure 14, with retraction (sucking in) of the eardrum 22.In adults, this is usually accompanied by some ear discomfort, afullness or pressure feeling and may result in a mild hearing impairmentand head noise (tinnitus). There may be no symptoms in children. If theobstruction is prolonged, fluid may be drawn from the mucous membrane ofthe middle ear 14, creating a condition we call serous otitis media(fluid in the middle ear). This occurs frequently in children inconnection with an upper respiratory infection and accounts for thehearing impairment associated with this condition.

A lining membrane (mucous membrane) of the middle ear 14 and Eustachiantube 26 is connected with, and is the same as, the membrane of the nose42, sinuses 44 and throat 32. Infection of these areas results in mucousmembrane swelling which in turn may result in obstruction of theEustachian tube 26. This is referred to as serous otitis media, i.e.,essentially a collection of fluid in the middle ear 14 that can be acuteor chronic, usually the result of blockage of the distal opening 28 ofthe Eustachian tube 26 which allows fluid to accumulate in the middleear 14. In the presence of bacteria, this fluid may become infectedleading to an acute suppurative otitis media (infected or abscessedmiddle ear). When infection does not develop, the fluid remains untilthe Eustachian tube 26 again begins to function normally, at which timethe fluid is absorbed or drains down the tube into the throat 32 throughthe Eustachian tube opening 28.

Chronic serous otitis media may result from longstanding Eustachian tubeblockage, or from thickening of the fluids so that it cannot be absorbedor drained down the Eustachian tube 26. This chronic condition isusually associated with hearing impairment. There may be recurrent earpain, especially when the individual catches a cold. Fortunately, serousotitis media may persist for many years without producing any permanentdamage to the middle ear mechanism. The presence of fluid in the middleear 14, however, makes it very susceptible to recurrent acuteinfections. These recurrent infections may result in middle ear damage.

When the Eustachian tube 26 contains a build-up of fluid, a number ofthings will occur. First, the body absorbs the air from the middle ear14, causing a vacuum to form which tends to pull the lining membrane andear drum 22 inward causing pain. Next, the body replaces the vacuum withmore fluid which tends to relieve the pain, but the patient canexperience a fullness sensation in the ear 10. Treatment of thiscondition with antihistamines and decongestants can take many weeks tobe fully effective. Finally, the fluid can become infected which ispainful and makes the patient feel ill and may not be able to hear well.If the inner ear 14 is affected, the patient may feel a spinning orturning sensation (vertigo). The infection is typically treated withantibiotics.

However, even if antihistamines, decongestants and antibiotics are usedto treat an infection or other cause of fluid build-up in the middle ear14, these treatments wilt typically not immediately resolve the pain anddiscomfort caused by the buildup of fluid in the middle ear 14, i.e.,the most immediate relief will be felt by the patient if the fluid canbe removed from the Eustachian tube 26.

Antibiotic treatment of middle ear infections typically results innormal middle ear function within three to four weeks. During thehealing period, the patient can experience varying degrees of earpressure, popping, clicking and fluctuation of hearing, occasionallywith shooting pain in the ear. Resolution of the infection occasionallyleaves the patient with uninfected fluid in the middle ear 14, localizedin the Eustachian tube 26.

Fluid build-up caused by these types of infections has been treatedsurgically in the past. The primary objective of surgical treatment ofchronic serous otitis media is to reestablish ventilation of the middleear, keeping the hearing at a normal level and preventing recurrentinfection that might damage the eardrum membrane and middle ear bones.

For example, as shown in FIG. 3, a myringotomy can be performed torelieve fluid in the middle ear 14. A myringotomy is an incision 42 inthe eardrum 22 performed to remove fluid in the middle ear 14. A hollowplastic tube 44, referred to as a ventilation tube, is inserted andlodged in the incision 42 to prevent the incision 42 from healing and toinsure ventilation of the middle ear 14. The ventilation tube 44temporarily takes the place of the Eustachian tube 26 in equalizing thepressure in the middle ear 14. The ventilation tube 44 usually remainsin place for three to nine months during which time the Eustachian tube26 blockage subsides. When the tube 44 dislodges, the eardrum 22 heals;the Eustachian tube 26 then resumes its normal pressure equalizingfunction.

Another method of relieving the pressure in the middle ear 14 is shownin FIG. 4 in which a hypodermic needle 46 is driven through the eardrum22 through which any accumulated fluid can be withdrawn from typicallyonly the upper portion of the Eustachian tube 26.

The methods of FIGS. 3 and 4 involve rupturing the eardrum 22 to relievethe fluid accumulation and pressure increase in the middle ear. Neitherof these methods, in addition to the sometimes permanent puncturecreated in the eardrum 22, is especially effective in removing all ofthe fluid in the Eustachian tube 26 since often the lower end 28 thereofis blocked and dammed with fluid.

In connection with the above surgical treatments of FIGS. 3 and 4,Eustachian tube 26 inflation is also employed to relieve the pressurebuild-up and fluid accumulation as shown in FIG. 5. The hypodermicsyringe 46 (shown with a flexible tip 48) is inserted into a nostril orinto the mouth until the tip 48 is positioned adjacent the distalopening 28 of the Eustachian tube 26 in the nasopharynx region 30 of thethroat 32. Air is blown through the tip 48 via the syringe 46 into theobstructed Eustachian tube 26 and, thus, into the middle ear 14 to helprelieve the congestion and reestablish middle ear ventilation. Thisprocedure is often referred to as politzerization. Politzerization ismost effective when one of the nostrils is pinched shut (as shown inFIG. 6), while the patient simultaneously swallows. This forces air intothe Eustachian tube 26 and the middle ear 14. This technique is good foropening the Eustachian tube 26 but it does not clear accumulated fluidaway.

Another method for clearing the middle ear 14 (at least temporarily) isreferred to as the “valsalva” maneuver accomplished by forcibly blowingair into the middle ear 14 while holding the nose, often called poppingthe ear. This method is also good for opening the Eustachian tube 26 butit does not clear the accumulated fluid away either.

Typical disorders associated with the middle ear and the Eustachian tubeinclude perforated ear drums, tympanosclerosis, incus erosion, otitismedia, cholesteotoma, mastoiditis, patulous Eustachian tithe, andconductive hearing loss. To treat some of these disorders, ear surgerymay be performed. Most ear surgery is microsurgery, performed with anoperating microscope. Types of ear surgery include stapedectomy,tympanoplasty, myringotomy and ear tube surgery.

One of the simplest ear surgeries is the myringotomy or the incision ofthe ear drum. However, ear surgery can also require the removal of thetympanic membrane for the visualization of the middle ear space. Oftensurgeons will try to preserve the integrity of the membrane by makingincisions in the skin of the ear canal and removing the tympanicmembrane as a complete unit. Alternatively, middle ear access isachieved via the mastoids. This method approaches the middle ear spacefrom behind the ears and drills through the mastoid air cells to themiddle ear. Whether the bony partition between the external ear canaland the mastoid is removed or not depends on the extent of the disease.Canal-wall-down refers to the removal of this bony partition.Canal-wall-up refers to keeping this bony partition intact. The termmodified radical mastoidectomy refers to an operation where this bonypartition is removed and the eardrum and ossicles are reconstructed. Aradical mastoidectomy is an operation where this bony partition isremoved and the car drum, malleus and incus bones are permanentlyremoved so that the inner lining of the large cholesteatoma sac can besafely cleaned. This operation is done when an extensive cholesteatomais encountered or one that is adherent to the inner ear or facial nerve.

Afflictions of the middle ear and Eustachian tubes are very prevalentand a serious medical problem, afflicting millions of people and causingpain, discomfort and even hearing loss or permanent ear damage. Althougha number of treatments have been developed, as described above each ofthem has shortcomings. Therefore, a need exists for improved methods andsystems for accessing, diagnosing and treating target tissue regionswithin the middle ear and the Eustachian tube. Ideally, such methods andsystems would be minimally invasive and pose very little risk of damageto healthy ear tissue.

BRIEF SUMMARY OF THE INVENTION

The embodiments of the present invention are directed toward methods andsystems for accessing, diagnosing and/or treating target tissue regionswithin the middle ear and the Eustachian tube. The healthy Eustachiantube opens naturally when adjacent muscles contract to vent the middleear and provide a gas pathway. Devices may be implanted within or alongthe Eustachian tube to help intermittently open the Eustachian tube. Onetype of device utilizes a valve tethered or otherwise operativelycoupled to muscles adjacent to the Eustachian tube, and particularly tomuscles responsible for opening the Eustachian tube. Such devices mayameliorate disorders which prevent the Eustachian tube from opening,including those caused by thickening of mucosal wall tissue or the like.In some embodiments, when the muscles contract the tethers will move andcause the valve to open and vent the middle ear. Another type of deviceutilizes compressive tethers on a portion of the mucosa and adjacentcartilage, to compress and shrink the mucosa and help the Eustachiantube open. Another device comprises an elongated spring, which can beimplanted within or along the Eustachian tube to aid in opening of theEustachian tube.

In one embodiment of the invention, a method for providing a gas pathwayin the middle ear region of a patient is provided. A guide wire isadvanced into the Eustachian tube (ET) of the patient via the patient'snasopharynx. An endoluminal ET ventilating implant is introduced via thepatient's nasopharynx along the guide wire into the Eustachian tube ofthe patient. The implant is advanced into the ET adjacent the cartilageand tensor villi palatine or the levator villi palatine muscles. Theimplant is dimensioned for insertion into the ET adjacent thenasopharynx. The implant is tethered to the ET cartilage using a firstconnector. The implant is tethered to the tensor villi palatine or thelevator villi palatine muscles using a second connector. A gas pathwayis provided between the ET lumen and the nasopharynx using the implant,the implant being dimensioned and configured to modulate an opening in agas pathway in communication with the ET lumen and the nasopharynx.

In many embodiments, the implant comprises a tube located in the ETlumen. In many embodiments, the implant further comprises a valve influid communication with the lumen, the valve having a first valveportion and a second valve portion, the first valve portion beingconnected with said first connector, and said second valve portion beingconnected with said second connector. The valve can be configured tomodulate the opening during swallowing due to movement of the tensorvilli palatine or the levator villi palatine muscles.

In many embodiments, the guide wire includes at least one marking andthe method further comprises viewing a location of the marking relativeto anatomy of the patient during the advancing method to determine howfar to advance the guide wire into the ET.

In another embodiment of the invention, an endoluminal implant forproviding a gas pathway between the nasopharynx and the Eustachian tube(ET) is provided. The implant comprises a lumen dimensioned forinsertion into the ET at an end adjacent the nasopharynx, through thepatient's nasopharynx. A valve is in fluid communication with the lumen.The valve has a first valve portion and a second valve portion. A firstconnector portion is connected with the first valve portion to tetherthe implant to the cartilage adjacent the ET. A second connector portionis connected with the second valve portion to tether the implant to theadjacent tensor villi palatine or the levator villi palatine muscles.

In many embodiments, the first connector portion comprises a firsttether configured to span across the cartilage and compress the mucosaof the ET lumen to secure the first valve portion with the cartilage.The proximal end of said first connector portion can have a T-shapedmember to secure against the cartilage.

In many embodiments, the valve is configured to modulate opening of theET during swallowing. The valve can be configured to modulate opening ofthe ET in response to the movement of the tensor muscles.

In yet another embodiment of the invention, another method for providinga gas pathway in the middle ear region of a patient is provided. Anendoluminal ET ventilating implant is introduced via the patient'snasopharynx into a Eustachian tube (ET) of a patient. A gas pathway isprovided between the ET lumen and the nasopharynx using the implant. Theimplant is dimensioned and configured to modulate an opening in a gaspathway in communication with the ET lumen and the nasopharynx. In manyembodiments, the implant comprises an elongated spring member whichapplies a constant force against the ET.

In yet another embodiment of the invention, another endoluminal implantfor providing a gas pathway between the nasopharynx and the Eustachiantube (ET) is provided. The implant comprises an elongated spring memberdimensioned for insertion into the ET at an end adjacent thenasopharynx, through the patient's nasopharynx. The elongated springmember applies a force to modulate an opening in a gas pathway incommunication with the ET lumen and the nasopharynx. In manyembodiments, the implant is configured to cause tissue ingrowth.

In yet another embodiment of the invention, another method for providinga gas pathway in the middle ear region of a patient is provided, Animplant is introduced via the patient's nasopharynx into a Eustachiantithe (ET) of a patient. The implant is coupled to adjacent cartilage tocompress a wall of the ET. A gas pathway is provided between the ETlumen and the nasopharynx using the tethering implant.

In yet another embodiment of the invention, another endoluminal implantfor providing a gas pathway between the nasopharynx and the Eustachiantube (ET) is provided. The implant comprises a first connector portion,and a member with a first end and a second end. The first end isconnected to the first connector portion. A second connector portion isconfigured to attach to the second end of the member. The member is of asuitable length, so that the member compresses a portion of the ET wallbetween the first and second ends.

For a further understanding of the nature and advantages of theinvention, reference should be made to the following description takenin conjunction with the accompanying figures. Each of the figures isprovided for the purpose of illustration and description only and is notintended to limit the scope of the embodiments of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross section of a human ear showing the inner, middle andouter ear portions and the Eustachian tube connecting the middle earwith the nasopharynx region of the throat via a distal opening thereof.

FIG. 2 is a cross section of a human head showing the nasopharynx regionof the throat illustrated in FIG. 1 containing the distal opening of theEustachian tube illustrated in FIG. 1.

FIG. 3 is a cross section of a human ear in the orientation shown inFIG. 1 showing a prior art surgical method for relieving fluid in themiddle ear in which a ventilation tube is placed within an incision inthe eardrum.

FIG. 4 is a cross section of a human ear in the orientation shown inFIG. 1 showing a prior art surgical method for relieving fluid in themiddle ear in which a syringe is shown having a needle perforating theeardrum.

FIGS. 5-6 show a cross section of a human head in the orientation shownin FIG. 2 showing a prior art politzeration method for relieving fluidin the middle ear in which a syringe is shown having a flexible tipextending into the nose and/or throat area so that the tip abuts thedistal opening of the Eustachian tube while the nose is plugged.

FIG. 7 shows a cross sectional view of a human head showing thenasopharynx region and a guide catheter in the nasal passage where thedistal tip of the guide catheter is adjacent the Eustachian tubeopening.

FIG. 8 shows a section of the anatomical region around a Eustachian tube(ET).

FIG. 9A shows a perspective view of a device for treating a disorder ofa Eustachian tube, according to one aspect of the invention.

FIGS. 9B and 9C show cross-sectional views of the device of FIG. 9A.

FIGS. 10A and 10B show perspective views of an anchoring member 912,according to one aspect of the invention.

FIGS. 11A-11C show cross-sectional views of a device being positionedwithin or along a Eustachian tube, according to one aspect of theinvention.

FIG. 11D shows a perspective view of a portion of a treated Eustachiantube, according to one aspect of the invention.

FIG. 12 shows a perspective view of a portion of a treated Eustachiantube, according to one aspect of the invention.

FIGS. 13A and 13B show perspective and side views, respectively, of adevice for treating a disorder of a Eustachian tube, according to oneaspect of the invention.

FIG. 13C shows a perspective view of a portion of a treated Eustachiantube, according to one aspect of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The embodiments of the present invention are directed toward methods andsystems for accessing, diagnosing and treating target tissue regionswithin the middle ear and the Eustachian tube.

Access

One embodiment of the present invention is directed toward usingminimally invasive techniques to gain trans-Eustachian tube access tothe middle ear. A middle ear space may be accessed via a Eustachian tube(ET). To obtain this access to the Eustachian tribe orifice, a guidecatheter having a bend on its distal tip greater than about 30 degreesand less than about 90 degrees may be used. Once accessed, diagnostic orinterventional devices may be introduced into the Eustachian tube.Optionally, to prevent damage to the delicate middle ear structures, asafety mechanism may be employed. In one embodiment, the safetymechanism may include a probe and/or a sensor introduced into the middleear via the tympanic membrane as shown in FIG. 7. For example, the probemay be an endoscope, and the sensor may be an electromagnetictransducer.

FIG. 7 is a cross sectional view showing the nasopharynx region and aguide catheter 100 in the nasal passage where the distal tip 102 of theguide catheter is adjacent the Eustachian tube opening. FIG. 7 shows theguide catheter 100 having a bend on its distal tip 102 that is greaterthan about 30 degrees and less than about 90 degrees located adjacentthe Eustachian tube orifice. A sensor 104 located adjacent the tympanicmembrane may be used to monitor advancement of the guide catheter. Thesensor is one example of a safety mechanism.

Diagnosis

Another embodiment of the present invention is directed to diagnosis ofthe condition of the middle ear and its structure. In one embodiment,diagnosis may include use of an endoscope that has been advanced intoposition through the guide catheter 100. The design of the endoscopewill allow for a 90 degree or more Y axis visualization and a 360 degreerotation. Such an endoscope may be used for assessment ofcholesteotomas, ossicle function and/or condition, and the surgicalfollow-up. An exemplary endoscope that may be adapted as described abovemay use the IntroSpicio 115 1.8 mm camera developed by Medigus. Such acamera measures approximately 1.8 mm×1.8 mm and its small rigid portionallows for the maximum flexibility at the endoscope tip.

Alternatively, ultrasound may be used by injecting a fluid into themiddle ear space and the ET and scanning the middle ear and the ET andits structure ultrasonically. Post-procedure the fluid may be aspiratedor left to drain through the Eustachian tube. An ultrasound tippedcatheter may be advanced up the ET to a position at the middle earcavity. The ultrasound catheter may then be pulled down the ET and thephysician may use an external video monitor to view the structure in andadjacent the ET.

Functional diagnosis of the Eustachian tube may be achieved via director indirect assessment. In one embodiment, for direct assessment, thediagnostic system may allow for the dynamic monitoring of the Eustachiantube during swallowing via a diagnostic probe inserted via thenasopharynx. Since such a diagnostic system may be used dynamicallyduring swallowing, the probe may be made of a flexible and durablematerial configured to be atraumatic. In one embodiment, the guidecatheter(s) 100 used in the nasopharynx approach may be removed once thediagnostic probe is in or near the ET region and prior to theswallowing.

In one embodiment, the diagnostic probe may comprise an endoscope tovisualize the ET structure and function. Alternatively, the diagnosticprobe may include a pressure transducer located on a catheter or a wire.When a pressure transducer is used, the pressure within the ET may bemonitored during swallowing and the pressure measurements may beinterpreted for ET opening function. Alternatively, an ultrasound probemay be inserted in the ET lumen to scan the ET region's structure. Fluidmay be introduced into the ET to facilitate ultrasound diagnosis. Forany of the above diagnostic systems, a single short length transducerthat is repositioned after each swallow may be used. Alternatively, anarray of transducers may be used to facilitate mapping of all or aportion of an ET.

The techniques described above may be used to directly access anddiagnose a Eustachian tube of a patient. In one embodiment, a method foraccessing a Eustachian tube of a patient may include inserting a guidecatheter into a nasal passage of the patient, the guide catheter havinga distal tip with a bend having an angle between about 30 and about 90degrees; and advancing the guide catheter in the nasal passage toward anopening of the Eustachian tube in the nasopharynx to place the distaltip adjacent the Eustachian tube opening. Additionally, the method mayalso include advancing a diagnostic device through the guide catheter toplace a distal tip of the diagnostic device adjacent the Eustachian tubeopening. The diagnostic device may include a diagnostic catheter. Thediagnostic device may include an endoscope, a pressure transducer, or anultrasound catheter.

Additionally, the method may also include introducing a diagnostic probeinto the Eustachian tube to directly assess Eustachian tube function. Itis preferred that the diagnostic probe is made from a flexible andEustachian tube compatible material. Alternatively, the diagnostic probemay comprise a pressure transducer located on a guide wire, and wherebythe method also includes monitoring pressure within the Eustachian tubewhile the patient is swallowing; and assessing an opening function ofthe patient's Eustachian tube using the monitoring. The method may alsoinclude removing the guide catheter after the diagnostic probe is placedinto the Eustachian tube. Additionally, or alternatively, the diagnosticprobe may comprise an ultrasound probe.

For indirect functional diagnosis of a Eustachian tube, in someembodiments, an external, energy source may be used to assess opening ofthe Eustachian tube. For example, possible energy sources may include,but are not limited to, pressure, sound, light or other electromagneticenergy. In one embodiment of indirect assessment, an emitter may bepositioned in the nasopharynx and a receiver may be placed at thetympanic membrane. Correlation between the emitted signal and thereceived signal may be translated into the physical characteristics ofthe ET during swallowing.

The techniques described above may be used to implement procedures forindirectly accessing and diagnosing the Eustachian tube of a patient.The indirect assessment method includes positioning an energy emitter inthe nasopharynx adjacent a Eustachian tube, positioning an energyreceiver adjacent the tympanic membrane via the external ear canal;directing energy from the emitter toward the receiver; generating anemitter signal representative of the energy from the emitter; generatinga receiver signal representative of the energy received by the emitter;forming a comparison between the emitter signal and the receiver signal;and indirectly assessing function of the Eustachian tube duringswallowing, using the comparison. The energy emitter can be a devicethat emits energy in the form of a pressure wave or electromagneticenergy. The indirect assessment may also include estimating the physicalcharacteristics of Eustachian tube.

Treatment

An embodiment of the present invention is directed toward the treatmentof Eustachian tube disorders. In some cases, for example, Eustachiantube disorders may be related to the Eustachian tube being unable toopen or close. In some cases mucosal tissue of the Eustachian tube maythicken, such that the adjacent muscles become ineffective in openingthe Eustachian tube in order to provide a gas pathway between theEustachian tube and the nasopharynx.

FIG. 9A shows a perspective view of a device 900 for supporting aEustachian tube, according to another embodiment of the invention. Thedevice 900 includes a lumen 902 which is in fluid communication with avalve 904. The lumen 902 is configured to be inserted into theEustachian tube, and accordingly includes a suitable length anddiameter, for example, approximately 35 mm and 1.5 mm respectively.Although the lumen 902 is shown with a circular profile, the lumen 902may be of other suitable shapes, such as a crescent, for matching thetransverse profile of the Eustachian tube. The lumen 902 can be madefrom a variety of materials, for example, biocompatible metals andpolymers. The lumen 902 can be constructed in a variety of ways, forexample, expandable mesh (stent), woven graft, or pre-formed (molded).In some embodiments, the lumen 902 can include therapeutic substanceswhich elute over time in order to provide a desired tissue response, forexample, causing tissue to grow into exterior portions of the lumen,and/or preventing tissue from growing excessively into the interior ofthe lumen.

The valve 904 is shown to include a first valve portion 906 and a secondvalve portion 908. The valve 904 is normally in a closed configurationwhen implanted, with the first and second valve portions sealinglyengaging each other, as the Eustachian tube is also normally closed. Thefirst and second valve portions are configured to open and close withphysiological movement of tissues near the Eustachian tube, typicallywith movement of the tensor villi palatine or the levator villi palatinemuscles (depending on which ear the device 900 is placed in), forexample, during swallowing. The first and second valve portions caninclude tethers 910 or other tension members. The members or tethers can(but need not) comprise laterally flexible tension members. One side ofthe tethers 910A can be connected to the tensor villi palatine or thelevator villi palatine muscles. Another side of the tethers 910B can beconnected to cartilage adjacent to the Eustachian tube. Accordingly,movement of the tensor villi palatine or the levator villi palatinemuscles will cause the tethers 910A to move and in turn cause the secondvalve portion 908 to separate from the first valve portion 906, andcause the Eustachian tube to open.

The tethers 910A are intended to be able to move with the tensor villipalatine or the levator villi palatine muscles, and are configured topass through the Eustachian tube wall. The tethers 910A may incorporateouter sleeves (not shown) for tissue to adhere to, but still allowmovement of the tethers 910. The tethers 910B are intended to passthrough the Eustachian tube wall and connect to adjacent cartilage. Thetethers 910B are not required to move. The tethers 910B can be ofappropriate length to compress surrounding mucosa and thus reduce theeffective inner diameter of the Eustachian tube. The tethers 910 areconnected to the appropriate muscles or cartilage through anchoringmembers 912 which anchor to tissue. The valve 903 is shown to occupy aportion of the lumen 902, however, in some embodiments the valve mayoccupy the entirety of the lumen when in the closed configuration. Insome embodiments, a plurality of valves 904 may occupy the lumen 902.

FIGS. 9B and 9C shows a cross-sectional views of the device 900. Thedevice includes a closed position as shown in FIG. 9B. The valve 904 isclosed when the tensor villi palatine or the levator villi palatinemuscles are not contracted, and not pulling on tethers 910A. The valve904 is open when the tensor villi palatine or the levator villi palatinemuscles contract or shorten, and pull on tethers 910A to move the secondvalve portion, as shown in FIG. 9C. A portion 902A of the lumen 902 maybe stretchable or foldable, such that when the valve 902 opens a pathwayis present between the first and second valve portions when the valve902 is open. Accordingly, the lumen 902 may comprise a stretchableand/or flexible material, such as silicone.

FIGS. 10A and 10B shows perspective views of an anchoring member 912according to one embodiment of the invention. In an unconstrainedconfiguration, the first component forms a generally T-configuration(FIG. 10B). When constrained within an anchor delivery device, the firstcomponent defines a substantially straight member (FIG. 10A). While thecomponent can be formed from a number of materials and manufacturedusing various conventional approaches. The anchoring member 912 can becut from a Nitinol™ tube using a laser. Using a superelastic materialsuch as Nitinol™ provides the component 82 with the resiliency totransform between a flipped T-configuration and a straightconfiguration.

As shown, the anchoring member 912 includes a first portion 84 which atone end defines a cylindrical structure and at the other a partialcylindrical structure. When unconstrained, this first portion 84 forms aT-bar or top of the anchoring member 82. A complementary partialcylindrical structure forms a mid-section or second portion 86 of theanchoring member 82 and operates as a spring to accomplish the flippingof the first portion 84 between constrained and unconstrainedconfigurations. When the component is in its constrained, straight form,the second portion is positioned adjacent the first portion 84. A thirdportion 88 is also cylindrical in shape and extends from the secondportion 86 away from the first portion 84. The third portion 88 canattach to one end of a tether 910. Another anchoring member can attachto the other end of the tether. One commonly skilled in the art wouldrecognize that other types of anchoring devices may be used or adapted,and devices for implanting such anchoring devices, for example, as shownand described in U.S. patent application Ser. No. 11/492,690,Publication No. 2007/0049929A1 know U.S. Pat. No. 7,896,891), theentirety of which is incorporated herein in its entirety.

FIG. 11A shows a partial cross-section of an Eustachian tube ET,including surrounding tensor villi palatine or the levator villipalatine muscles M, and adjacent cartilage C. The device 900 has beenplaced using a guide wire 916. The guide wire 916 is inserted via apatient's nasopharynx. A suitable nasal endoscope may be used to placethe guide wire. The guide wire 916 can include a marker 916M to whichcan be aligned with a feature of the Eustachian tube, such as the entryway, to determine how far to advance the guide wire into the Eustachiantube. The device 900 is shown placed in the Eustachian tube ET. Thedevice 900 is shown in an expanded state for the sake of clarity, butmay be collapsed around the guide wire in actual use.

FIG. 11B shows a partial cross-section of the Eustachian tube ET of FIG.11A. A catheter 918 is advanced over the guide wire 916 and placedpartially within the device 900. The catheter 918 includes a hollowneedle 920 which is advanced through an opening within the device 900about valve 902 and through the Eustachian tube ET and tensor villipalatine or the levator villi palatine muscles M. A tether 910A and twoconnected anchoring members 912A, 912B reside within the needle.Anchoring member 912A can be ejected from the needle 920 within or alongthe tensor villi palatine or the levator villi palatine muscles M. Theanchoring member 912A can then form a T-shape as discussed herein, andanchor itself within or along the tensor villi palatine or the levatorvilli palatine muscles M. The needle 920 may then be withdrawn to aposition about the device 900 and anchoring member 912B may be ejectedfrom the needle 920. The anchoring member 912A can then form a T-shape,and anchor itself to the device 900. The tether 910A connects theanchoring members 912A, 912B. At least one tether may also be placedinto the cartilage C using the same method.

FIG. 11C shows a partial cross-section of the Eustachian tube ET of FIG.11A. The device 900 is shown connected about valve 902 to the tensorvilli palatine or the levator villi palatine muscles M by at least onetether 910A. The device 900 is also shown connected about valve 902 tothe cartilage C by a tether 910B. Shortening or contraction of thetensor villi palatine or the levator villi palatine muscles M can openthe valve 902, for example, during swallowing. Thus, the device canprovide a gas pathway between the ET lumen and the nasopharynx.

FIG. 11D shows a perspective view of the device 900 implanted within oralong to a Eustachian tube. Multiple tethers 910A connect the secondvalve portion 908 to the tensor villi palatine or the levator palatinemuscles M. Similarly, multiple tethers 910B connect the first valveportion 906 to the cartilage C. The device 900 is shown in a closedposition with the first and second valve portions in contact with eachother. The Eustachian tube is normally closed with the posterior andanterior walls of the Eustachian tube in contact. The Eustachian tubeopens to relieve pressure or fluids upon contraction of the tensor villipalatine or the levator villi palatine muscles M, and thus separate theanterior wall AW from the posterior wall PW.

FIG. 12 shows a perspective view of a portion of a Eustachian tube ET.As noted above, Eustachian tube disorders can originate from athickening of the mucosa MU on the posterior wall of the Eustachiantube. When the mucosa MU becomes too thick, contraction of the tensorvilli palatine or the levator villi palatine muscles M can beineffective to open the Eustachian tube. Tethers 1200 are shown at leastpartially implanted within or along the mucosa MU with anchors 1202,1204 positioned within or along the cartilage C and mucosa MU. Thetethers 1200 and anchors 1202, 1204 can be implanted as similarlydiscussed herein. The tethers 1200 can be of an appropriate length, forexample as long as the transverse thickness of a normal mucosa, whichmay be patient dependent, in order to compress and shrink the thickenedmucosa MU to a normal thickness. Accordingly, contraction of the tensorvilli palatine or the levator villi palatine muscles M can then beeffective in separating the anterior wall AW from the posterior wall PWof the compressed Eustachian tube. A plurality of tethers can be placedthroughout the Eustachian tube. In some embodiments, the tethers oranchors are attached to support members (not shown) placed within oralong the Eustachian tube, for supporting the tissue of the Eustachiantube and/or to provide a valve.

FIGS. 13A and 13B show perspective and end views, respectively, of aspring member 1300 for supporting a Eustachian tube. The spring member1300 can be configured in an elongated clamshell configuration as shown.A first portion 1302 of the spring member 1300 is configured to bepositioned along and/or a the posterior wall of the Eustachian tube. Asecond portion 1304 of the spring member 1300 is configured to bepositioned along and/or about the posterior wall of the Eustachian tube.The first portion 1302 and the second portion 1304 can be spring biasedaway from each other according to a spring force F to resist the firstportion 1302 and the second portion 1304 from coming into contact withone another, with the spring force optionally being substantiallyconstant. The spring member 1300 can comprise a variety of metals andpolymers. In some embodiments, the spring member 1300 can be constructedfrom a plurality of biased wires (shaped in the profile of FIG. 13B)connected by a membrane of material. In some embodiments, the springmember 1300 can be constructed from a single piece of flat material. Insome embodiments, the spring member 1300 can be constructed from mesh ofinterwoven material. In some embodiments, the spring member 1300 can becoated or imbedded with a therapeutic substance, for example, toencourage tissue growth, limit stenosis of the Eustachian tube, and/orthe like.

FIG. 13C shows a perspective view of a portion of a Eustachian tube ET.The spring member 1300 is shown implanted sub-mucosally along theEustachian tube ET. The first portion 1302 and the second portion 1304of the spring member 1300 are shown implanted along the Eustachian tube,with the first portion 1302 located behind the posterior wall PW, andthe second portion located behind the anterior wall AW. The springmember 1300 serves to aid opening of the Eustachian tube as the springforce F helps separate the anterior wall AW from the posterior wall PW,and thus serve as an aid to the tensor villi palatine or the levatorvilli palatine muscles M. In some embodiments, the spring member 1300may be surgically implanted behind the anterior wall AW and posteriorwall PW, for example by an incision. In some embodiments, the springmember 1300 may include a substance which causes a tissue response togrow into or over the spring member 1300. In some embodiments, thespring member 1300 may be permanently or temporarily positioned on theexterior of the anterior and posterior walls. In some embodiments, thespring member 1300 is biased toward a closed configuration to keep theEustachian tube closed in the case of a patulous Eustachian tube.

The present invention may be embodied in other specific forms withoutdeparting from the essential characteristics thereof. For example,devices and methods for accessing the Eustachian tube as disclosed inco-assigned U.S. patent application Ser. No. 12/340,226 (published asU.S. Pat. Pub. No. 2009/0163890), the entirety of which is incorporatedby reference herein, may be used in conjunction with the instantdisclosure. These other embodiments are intended to be included withinthe scope of the present invention, which is set forth in the followingclaims.

What is claimed is:
 1. An endoluminal implant for providing a gaspathway between a nasopharynx and a Eustachian tube (ET) of a patient,the endoluminal implant comprising: (a) a body dimensioned for insertioninto the ET, wherein the body defines a lumen; and (b) a valveconfigured to modulate opening and closing of the lumen in response tomovement of tissue associated with the ET, wherein the valve comprises:(i) a first valve portion; and (ii) a second valve portion, wherein thefirst and second valve portions are movable relative to one anotherbetween a closed state in which the valve portions are configured tosealingly engage one another to thereby restrict flow of gas through thelumen, and an open state in which the valve portions are configured toseparate to thereby permit flow of gas through the lumen.
 2. Theendoluminal implant of claim 1, wherein the endoluminal implant furthercomprises: (i) a first coupling member configured to couple the firstvalve portion to tissue adjacent to the ET, and (ii) a second couplingmember configured to couple the second valve portion to tissue adjacentto the ET.
 3. The endoluminal implant of claim 2, wherein the firstcoupling member comprises a first tether and the second coupling membercomprises a second tether, wherein the first and second tethers areconfigured to extend transversely through a wall of the ET to couple torespective tissue.
 4. The endoluminal implant of claim 2, wherein thefirst coupling member is configured to couple the first valve portion tocartilage, wherein the second coupling member is configured to couplethe second valve portion to a tensor villi palatine muscle or a levatorvilli palatine muscle.
 5. The endoluminal implant of claim 2, whereinthe first and second coupling members are configured to compress mucosaof the ET and thereby reduce an inner diameter of the ET.
 6. Theendoluminal implant of claim 2, wherein the first coupling memberincludes a first anchoring member configured to anchor the firstcoupling member to tissue, wherein the second coupling member includes asecond anchoring member configured to anchor the second coupling memberto tissue.
 7. The endoluminal implant of claim 6, wherein each of thefirst and second anchoring members is configured to assume a T-shapedconfiguration.
 8. The endoluminal implant of claim 1, wherein a portionof the lumen is configured to expand from a first cross-sectional widthwhen the first and second valve portions are in the closed state, to alarger second cross-sectional width when the first and second valveportions are in the open state.
 9. The endoluminal implant of claim 8,wherein the portion of the lumen comprises a flexible material.
 10. Theendoluminal implant of claim 1, wherein the lumen contains a therapeuticsubstance configured to elute into tissue surrounding the lumen.
 11. Theendoluminal implant of claim 10, wherein the therapeutic substance isconfigured to at least one of: (i) promote growth of tissue intoexterior portions of the lumen, or (ii) prevent growth of tissue intointerior portions of the lumen.
 12. The endoluminal implant of claim 1,wherein the lumen comprises at least one of an expandable mesh, a wovengraft, or a molded structure.
 13. The endoluminal implant of claim 1,wherein the first valve portion has a first sealing surface, wherein thesecond valve portion has a complementary shaped second sealing surfaceconfigured to sealingly engage the first sealing surface when the firstand second valve portions are in the closed state.
 14. The endoluminalimplant of claim 1, wherein the lumen is configured to receive aguidewire longitudinally therethrough.
 15. The endoluminal implant ofclaim 14, wherein the lumen is further configured to receive a catheterover the guidewire.
 16. An endoluminal implant for providing a gaspathway between a nasopharynx and a Eustachian tube (ET) of a patient,the endoluminal implant comprising a body dimensioned for insertion intothe ET, wherein the body comprises: (i) a first body portion, (ii) asecond body portion movably coupled to the first body portion, and (iii)an open interior defined between the first and second body portions,wherein the first and second body portions are resiliently biased awayfrom one another and are configured to exert an outwardly directed forceon the ET to thereby bias the ET toward an open state.
 17. Theendoluminal implant of claim 16, wherein the first and second bodyportions are coupled together in an elongate clamshell configuration.18. The endoluminal implant of claim 16, wherein the first body portionis configured to be positioned behind a posterior wall of the ET,wherein the second body portion is configured to be positioned behind ananterior wall of the ET.
 19. An endoluminal implant for providing a gaspathway between a nasopharynx and a Eustachian tube (ET) of a patient,the endoluminal implant comprising: (a) an elongate body defining alumen, wherein the elongate body is dimensioned for insertion into theET; (b) a first movable portion; and (c) a second movable portion,wherein the first and second movable portions are configured to movetransversely toward one another to thereby restrict flow of gaslongitudinally through the lumen, wherein the movable portions areconfigured to move transversely away from one another to thereby permitflow of gas longitudinally through the lumen.
 20. The endoluminalimplant of claim 19, wherein the first and second movable portions areconfigured to move relative to one another in response to movement of atleast one of a tensor villi palatine muscle or a levator villi palatinemuscle.